The following information outlines the holiday schedule for the CCTS Regulatory office:
- Thursday, Nov. 22 (Thanksgiving Day) – Regulatory will be closed
- Friday, Nov. 23 (day after Thanksgiving) – Regulatory will be closed
- Thursday, December 6th, Regulatory will be closed from 11:30am-1:30pm for a CCTS-sponsored function.
- Monday, Dec. 24 (Christmas Eve) - Tuesday, Jan. 1 (New Year’s Day) – Regulatory will be closed. We will reopen Wednesday, Jan. 2.
Please note: With the cold weather coming soon, we want you to be aware that when the University announces planned delays or closure (Plan B), the regulatory office will be delayed in opening or will be closed.
If you have questions, need further clarification, or if any of the above presents a problem to you or your research team, please contact Marietta Barton-Baxter to discuss potential alternatives (257-6462).
The CCTS Regulatory Knowledge and Support core can help investigators navigate the study start-up process by providing the following services:
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2 hour complimentary consultation
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Assistance with IRB and/or FDA Submissions
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Assistance with Protocol Development
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Creation of Regulatory Binder
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Assistance with Regulatory documents (i.e. 1572, Financial Disclosure, Site Signature, Delegation log, CV, Medical License, Laboratory certification, etc.)
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Serve as a liaison with study sponsor
Other Resources
- Certificate of Confidentiality (COC)
- Clinical Trial Agreements (CTA)
- Confidential Disclosure Agreement (CDA)
- Conflict of Interest
- Insurance Coverage Analysis
- ClinicalTrials.gov (CT.gov)
- Investigational Drug Service (IDS)
- Office of Research Integrity (ORI)
- Institutional Biosafety Committee (IBC)
- Markey Cancer Center Clinical Research Office
- VA Research and Development
Contacts
William Stoops, PhD
- Director, Regulatory Knowledge and Support Core
- william.stoops@uky.edu
- (859) 257-5388
Ada Sue Selwitz, MS
- Co-Director, Regulatory Knowledge and Support Core
- ada.selwitz@uky.edu
- (859) 257-9454
